Tag Archives: thrombin

High Strength Medical and Surgical Glues

See the updated, published 2012 Report #S190, “Surgical Sealants, Glues, Sutures, Other Wound Closure and Anti-Adhesion, Worldwide Markets, 2012-2017.”

Cyanoacrylate products are the main form of high-strength surgical glue that is approved for human clinical use in the worldwide market. A number of new materials are under development for internal use in particular, but these represent new chemical entities and their commercialization is likely to be delayed by regulatory requirements.  While sutures will be replaced by cyanoacrylate glues in many procedures over the next 10 years, this will only occur after some technical challenges are overcome. For example, cyanoacrylate glues used for external skin closure are approximately five times less strong than sutures, and cyanoacrylates produce cytotoxic compounds as part of the curing process when used for securing torn or excised tissue. This has delayed the development and clinical evaluation of these potentially useful materials for internal surgical procedures. However, cyanoacrylate glues are marketed actively by a number of companies for topical wound closure in accident/emergency situations and in surgical closure.

Given the current size of the global market for high strength glues (at over $700 million) and the potential for this market to expand as products overcome the challenges of strength and toxicity, a respectable number of competitors compete in this space and many are working on further developing cyanoacrylate-based and other high strength adhesives (including fibrin-based and other “bio-glues”) to not only garner greater share of the existing market but to also erode the market for sutures and other mechanical wound closure products (e.g., clips and staples).

Source: MedMarket Diligence Report #S180, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2015.”

Ethicon (J&J), Covidien and B. Braun (Aesculap) hold the major positions in the market for high strength medical and surgical adhesives, but their positions are at risk, and will continue to be at risk, as long as the unmet need exists for stronger, more compatible glues.  Some of the many products on the market and in development in the area of high strength glues include SurgiSeal, DermaSeal, FloraGuard, LiquiBand, SkinLink, Histoacryl, Gluetiss, Autologous biological glue, Chemence USP Class VI adhesives, TissueGlu, Indermil, Glubran2, Glubran Tiss, GluSeal, GluSite, PeriAcryl, GluShield, Dermabond, InteguSeal, Epiglu, Surgical Tissue Sealants (STS) and others.

Sutureless Vascular Anastomosis and Other Applications of Sealants and Glues

(Note: This was posted initially in August 2011. The data in the table is drawn from the 2012 updated, published report #S190.)

In light of the recent development in which Stanford researchers invented a method for a sutureless attachment of blood vessels (i.e., vascular anastomosis) using a surgical glue (Dermabond), it is worth highlighting that the applications of surgical sealants and glues in medical/surgical applications are remarkably numerous, with a potential already begun to be realized in reshaping many medical and surgical procedures.

Below is an excerpt of the clinical applications by major field for surgical sealants and glues (drawn from Report #S190):

Surgical Field
Applications
CNS surgery:* Adhesive agent in CNS tissue surgery. CNS tissue cannot be sutured. Fibrin glue is almost equivalent to microsurgical suture. Fibrin glue works as a sealant but not a nerve barrier.
* Repair of dural defects.
* Others
Eye surgery:* Conjunctival closure in strabismus.
* Wound closure in glaucoma.
* Lower blepharoplasties (for lower eyelids).
* Others
ENT surgery:* Myringoplasty in large persistent tympanic membrane perforation.
* Repair of laryngotracheal separation with cricoidectomy.
* Narrowing of nasal fossa in atrophic rhinitis.
* Others
Oral and dental surgery:* Local hemostatic measures in patients with bleeding disorders and patients on anticoagulants.
* Sealing of oro-antral fistula.
* Others
Head and neck:* Parotidectomy closure.
* Axillary dissection in carcinoma of the breast. Reduces adhesion, bleeding and serous drainage with earlier drain.
* Prevention of mastectomy seroma.
* Others
Cardiovascular thoracic surgery:* Reduced postoperative bleeding and intrapericardial adhesion.
* In cardiothoracic surgery using fibrin glue significantly reduced postoperative bleeding.
* Others
Chest surgery:* Sealing of prolonged air leak after thoracotomy in lung cancer.
* Bronchopleural fistula.
* Percutaneous lung biopsy.
* Others
Vascular surgery:* Microvascular anastomosis: Suture may induce vascular narrowing, foreign body reaction, intravascular thrombosis but are less common in those with fibrin glue application.
* Others
Gastrointestinal surgery:* Gastrointestinal sutureless anastomosis-stent.
* Esophagus perforation.
* Esophago-jejunal anastomosis.
* Recurrent tracheo-esophageal fistula.
* Upper gastrointestinal tract fistula: Endoscopic obliteration.
* Cholecysto-jejunostomy (sutureless) using absorbable intraluminal stent.
* Others
Liver surgery:* Liver resection in benign and malignant diseases.
* Others
Uro/Gynecological system:* Colpofixation in stress urinary incontinent.
* Intractable transplant-ureteral fistula.
* Transvaginal colpo-urethropexy.
* Others
Gynecological surgery:* Recto-vaginal and ano-rectal fistula.
* Anastomosis of the fallopian tube in animals.
* Others
Bone & orthopedic surgery:* Joint replacement.
* Brachial plexus injury repair.
* Others
Plastic surgery:* Face lift procedure. Fibrin glue reduces major hematomas and ecchymoses.
* Musculo facial plastic surgery, dorsal hand burns, infected skin graft.
* Decrease wound contraction in skin graft.
* Others

Note: “Others” are detailed in Report #S190.

Source: MedMarket Diligence, LLC; Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2012-2017.”